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Actos and Bladder Cancer

Both France and Germany have suspended the sale of pioglitazone over concerns of Actos bladder cancer risks. The link between the blockbuster diabetes medication and cancer has been established in numerous medical studies, one of which was ordered by the U.S. Food and Drug Administration (FDA), after the agency received 93 adverse events from 2004 through 2009 regarding bladder cancer due to Actos ingestion.

In 2011, the FDA determined that Actos exposure for one year or longer can increase a person’s risk for developing bladder cancer as much as 40 percent. Despite this alarming statistic, and many others like it, Actos remains on U.S. shelves and continues to generate millions of dollars in revenues for manufacturer, Takeda Pharmaceuticals.

Actos is a type of thiazolidinedione or TZD class of Type 2 diabetes medications that was approved by the FDA in 1999. Over the years, TZDs have been shown to be very effective at reducing insulin resistance and enhancing beta cell function in Type 2 diabetics. Despite its efficacy in stabilizing blood sugar levels, pioglitazone has also been associated with disturbing side effects, including congestive heart failure, bone fractures and lactic acidosis. Bladder cancer remains the most well-known of Actos side effects, and is the complication most cited in current litigation pending against Takeda.

Actos suspended in Europe due to safety concerns

Public awareness of Actos and bladder cancer risks grew considerably when the French Agency for the Safety of Health Products decided to pull the medication from shelves in 2011. The so-called Actos recall was based on the findings of an epidemiological study that revealed long-term Actos ingestion significantly increased risk of bladder cancer compared to other diabetes medications. Germany followed suit the same month, cautioning physicians not to prescribe Actos until further research was conducted on cancer risks.

Clinical research on rates of bladder cancer diagnoses among diabetes patients include a study published by the British Medical Journal in 2012. Researchers compared data of 115,000 patients treated with drugs like Actos from 1988 to 2009. Individuals who were taking pioglitazone were found to have an 83% increased risk for developing cancer of the bladder – more than double that found in the FDA’s Actos warning issued in 2011. “Patients with type 2 diabetes and their physicians need to be fully aware of the potential association between Actos and bladder cancer,” warned lead researcher, Laurent Azoulay PhD.

Bladder cancer risk factors

Those diagnosed with type 2 diabetes are already at a higher risk for bladder cancer, according to The National Cancer Institute. And while the medical community is still divided on how Actos causes cancerous cells to form, some scientists speculate the danger lies in the way TZD’s function by making the body more receptive to insulin.

Beyond Actos exposure for prolonged periods of time, other risk factors for developing bladder cancer include:

  • Tobacco use: Cigarette, pipe and cigar smoking can also elevate the risk of developing bladder cancer. Studies have found that smokers are up to 7 times more likely to develop bladder cancer than nonsmokers.
  • Gender:  Men are four times more likely to develop bladder cancer compared to women, but females are more likely to die of the disease.
  • Race: Caucasians have twice the risk as African Americans for developing bladder cancer.
  • Chemicals exposure: Toxic chemicals used in leather, textile, and dye industries can heighten the risk for bladder cancer.
  • Age:  More than 70% of individuals diagnosed with bladder cancer are age 65 or older.
  • Family or personal history of cancer: Bladder cancer has a high reoccurrence rate, so those with a personal history of the disease are more prone to a repeat diagnosis.
  • Reoccurring bladder problems: Chronic bladder infections and bladder stones are associated with a greater bladder cancer risk.
  • Chemotherapy medications: Patients who have been exposed to the chemotherapy drug cyclophosphamide (Clafen, Cytoxan, Neosar) have an increased risk.

Signs and symptoms of bladder cancer

Unfortunately, bladder cancer doesn’t always carry obvious symptoms, especially in its early stages.

The most common indicators of the disease include:

  • Pain when urinating
  • Feeling the need to urinate frequently, but unable to pass urine
  • Blood in the urine (occurs in 9 out of 10 patients)
  • Lower back pain around the kidneys
  • Unexplained weight loss
  • Frequent urinary tract infections
  • Pelvic mass
  • Anemia

Actos bladder cancer prognosis

The good news for individuals who are diagnosed with bladder cancer is that the disease can be treated successfully when caught early on. The five-year survival rate is nearly 80%, but bladder cancer reoccurrence is common, even when treated early.

Since symptoms of bladder cancer are often subtle and go undetected for months, some diabetes patients are already at an advanced stage of the disease once it is discovered. Patients who are on Actos are advised by the FDA to tell their doctor immediately if they notice any signs such as blood or red color in the urine, an urgent need to urinate, or general pain while urinating.

Utilizing a combination of urine tests, biopsies, diagnostic cytoscopies, CT scans and/or MRIs, physicians can accurately assess the stage of bladder cancer and the recommended course of treatment.

Depending on the invasiveness and stage (stage oA through Stage IV) of the cancer and the patient’s overall health, treatment may include:

  • Surgery to remove the cancerous tumor and surrounding tissue
  • TURBT with fulguration, where the surgeon removes the bladder cancer using a tool with a wire loop or a laser
  • Radiation therapy
  • Systemic chemotherapy and immunotherapy
  • Clinical trials using innovative therapies

Though most bladder cancer treatments are successful, the disease may metastasize to other parts of the body, and be diagnosed as terminal.

Failure to warn of bladder cancer risk fuels litigation

With hundreds of patients blaming side effects of Actos for their bladder cancer diagnoses, product liability litigation against Takeda continues to escalate. Legal insiders told Bloomberg News that the pharmaceutical giant may eventually face more than 10,000 Actos lawsuits, each alleging negligence, misrepresentation and failure to warn of bladder cancer risks. For many of the plaintiffs who had taken pioglitazone since its 1999 launch, the FDA Actos warning came far too late.

Actos lawsuits allege that Takeda was aware of the dangers in 1999, when rats developed cancerous tumors during pre-market clinical trials.   The drug maker is accused of placing profits above the safety and welfare of the general public, and is being sued in state and federal courts around the nation.

  1. FDA,  Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer,
  2. LA Times, Study: Diabetes drug Actos doubles the risk of bladder cancer,
  3. US News Health, Another Study Links Diabetes Drug Actos to Bladder Cancer,
  4. MedPage Today, Actos Bladder Cancer Risk Again Affirmed,
  5., Bladder Cancer,